Fampyra - fampridine

What is Fampyra - fampridine?

Fampyra is a medicine containing the active substance fampridine. The medicine is available as prolonged-release tablets (10 mg).

What is Fampyra - fampridine used for?

Fampyra is indicated for the improvement of gait in adult patients with multiple sclerosis (MS) with walking disabilities.

Multiple sclerosis is an inflammatory disease that affects the nervous system, with a progressive destruction of the protective sheath that covers the nerves.

The medicine can only be obtained with a prescription.

How is Fampyra - fampridine used?

Treatment with Fampyra should only be carried out on prescription and supervision by a physician experienced in managing multiple sclerosis. The recommended dose is one tablet taken orally, twice a day, 12 hours apart. The tablets should be taken without food.

Patients should be examined two weeks after treatment; treatment must be stopped if no improvement is observed. Treatment should also be discontinued in the event of impaired walking or if the patient does not report benefiting from treatment.

How does Fampyra - fampridine work?

The body's muscles contract because they receive electrical impulses that are transmitted through the nervous system. In multiple sclerosis the transmission of electrical impulses is impaired when the protective sheath that covers the nerves is damaged. The result is muscle weakness, muscle stiffness and difficulty in walking.

The active substance in Fampyra, fampridine, is a potassium channel blocker. It acts on damaged nerve structures, preventing potassium particles from leaving nerve cells. It is believed that in this way it produces the effect of allowing the electrical impulse to continue to propagate along the nervous system to stimulate the muscle, making walking easier.

What studies have been conducted on Fampyra - fampridine?

The effects of Fampyra were first tested in experimental models before being studied in humans. The company has also presented data from the scientific literature.

Two important studies were conducted in which Fampyra was compared with placebo (an ineffective substance on the body) in 540 patients with multiple sclerosis. Patients were treated for 9 or 14 weeks. The main indicator of effectiveness was represented by improvements in walking speed along a course of about 7.5 meters. Patients were thought to have responded to treatment if, on at least three out of four occasions, their walking speed was higher than the maximum speed recorded before treatment.

What benefit has Fampyra - fampridine shown during the studies?

Fampyra was effective in improving walking speed. In one of the main studies, approximately 35% of patients treated with Fampyra responded to treatment compared to 8% of subjects treated with placebo. Similar results emerged from the second study: 43% of patients in the Fampyra group responded to treatment compared to 9% of subjects in the placebo group.

What is the risk associated with Fampyra - fampridine?

The most common side effects of Fampyra are predominantly neurological (ie detectable at the nervous or cerebral level), namely convulsions, insomnia, anxiety, balance problems, dizziness, paresthesia (abnormal sensations such as tingling and prickling), tremors, mal of head and fatigue (weakness). The most common side effect reported in clinical studies, which affects approximately 12% of patients, is urinary tract infection. For the full list of all side effects reported with Fampyra, see the Package Leaflet.

Fampyra should not be used in people who may be hypersensitive (allergic) to fampridine or any of the other ingredients. It must not be used with other medicines containing fampridine or with medicines known as "organic cation transporter 2 inhibitors" such as cimetidine. Fampyra cannot be used in patients who have had convulsions in the past or in patients with kidney problems.

Why has Fampyra - fampridine been approved?

The CHMP considers it probable that Fampyra will benefit about one third of MS patients with walking disabilities and that these benefits can be identified in these subjects at an early stage of treatment, which allows treatment to be stopped in other subjects. The committee noted that other treatments for the treatment of the symptoms of multiple sclerosis are not currently authorized and that serious side effects with Fampyra are rare. The CHMP therefore concluded that the benefits of Fampyra are greater than its risks in patients with walking disabilities and recommended that it be given marketing authorization.

Fampyra has obtained "conditional approval". This means that further data are expected, in particular with regard to the long-term effects of the drug on other aspects of walking ability. The European Medicines Agency reviews the new information available every year and, if necessary, updates this summary.

What measures are being taken to ensure the safe use of Fampyra - fampridine?

The company that makes Fampyra will carry out a long-term study on the efficacy and safety of the medicine. The study will examine the effects of Fampyra on other aspects of walking, in addition to speed, and will seek new ways to identify patients responding to Fampyra early, to allow timely intervention on treatment management.